Model Number 101/860/070 |
Device Problems
Inflation Problem (1310); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: month and year of event have been provided; day is unknown.D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that there was a leak from the cuff and the cuff did not inflate.There was patient involvement and no patient harm/adverse event reported.
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Manufacturer Narrative
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H3 and h6.Evaluation codes: updated.Device evaluation: one used decontaminated device sample was returned for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.During functional inflation testing it was found that it is difficult to inflate the cuff, the cuff leaks.Inflated cuff by a syringe filled with air and placed the device under water.An air leak was detected from the pilot balloon and a hole was visible.The complaint was confirmed.Because the failure was observed during use (not prior to use as required by ifu) it is most probable that the failure happened due to poor user handling.A device history record (dhr) review could not be performed as the lot number was unknown.No action was taken, and no trend of similar customer complaints was identified.D4 - partial udi provided.
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Search Alerts/Recalls
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